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Идёт набор NCT05985148

A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall

Фаза I С лечением Thoracoabdominal Wall Pain Secondary to Parietal Pleura or Parietal Peritoneum Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Single-fraction stereotactic radiosurgery (SRS).
Кому может быть актуально
Состояния в реестре: Thoracoabdominal Wall Pain, Secondary to Parietal Pleura or Parietal Peritoneum Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Phase I Dose Escalation Trial for Treatment of Chronic Thoracoabdominal Wall Pain Through Ablation of the Dorsal Spinal Nerve Using Single-Fraction Stereotactic Radiosurgery

Обзор

The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will test different doses of SRS to find the highest dose that causes few or mild side effects.

Вмешательства

  • Лучевая терапия Single-fraction stereotactic radiosurgery (SRS)
    Patients will be treated with single-fraction radiation therapy at three dose levels: 70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.

Первичные конечные точки

  • can be escalated from 70 Gy to 90 Gy without excessive DLTs [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic paravertebral nerve block or TENS (if results of the paravertebral nerve block are inconclusive) performed by an attending anesthesiologist specializing in pain management prior to study enrollment.
  • Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with conventional pharmacologic therapy for analgesia) as determined by an attending physician specializing in pain management.
  • KPS ≥ 60%
  • Age ≥ 18 years old

Критерии исключения

  • Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
  • Patients with active autoimmune connective tissue disease
  • Patients with bilateral TAWP
  • Patients with preexisting pneumothorax
  • Patients with preexisting excessive pleural effusion (extending > 3 vertebral levels)
  • Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
  • Unable to undergo a diagnostic paravertebral nerve block
  • Unable to undergo at least one of either a myelogram or spine MRI
  • Patients for whom external beam treatment plans to deliver the prescription SRS dose to the lesion of interest cannot be safely designed as specified by the Dose Constraint Guidelines in Appendix 2
  • Evaluation of any radiation doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum) will be taken into consideration
  • If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
  • Abnormal complete blood count. Any of the following:
  • Platelet count < 75 K/µL
  • Hgb level < 9 g/dl
  • WBC < 3.5 K/µl
  • Abnormal coagulation profile: INR > 2.5 INR and/or APTT > 80 seconds. Patients who are on anticoagulation medication that may not be safely held for the myelogram procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
  • Allergy to local anesthestics
  • Local infection at the site of injection of anesthetic
  • Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
  • Severe respiratory disease (i.e. oxygen dependent)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT05985148 · 22-176

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗